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The Effects of Coenzyme A Combined With Abiraterone on Patients With CRPC (CoA-CRPC)

Primary Purpose

Castration-resistant Prostate Cancer

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Coenzyme A Combined With Abiraterone
Abiraterone
Sponsored by
Jiangnan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Castration-resistant Prostate Cancer

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

- 18-100 years of age combined use with abiraterone or enzalutamide CRPC

Exclusion Criteria:

- pregnancy acute liver disease or hepatic dysfunction, as determined by levels of alanine aminotransferase (ALT) or aspartate aminotransferase levels (AST) more than 2-fold the upper normal limit nephrotic syndrome or serum creatinine (Cr) ≥2-fold the upper normal limit and creatine phosphokinase (CK) more than 3-fold the upper normal limit primary hypothyroidism psychiatric patients poorly controlled hypertension, as indicated by a Systolic Blood Pressure >180 mmHg or Diastolic Blood Pressure >110 mmHg using contraceptive agent using immunosuppressive drugs, prohibited medication or other non-PCa drugs long-term using CoA drug

Sites / Locations

  • Jiangnan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental: Coenzyme A 200U

Placebo Comparator: Placebo

Arm Description

Coenzyme A 200U per day

Abiraterone without coenzyme A

Outcomes

Primary Outcome Measures

Total prostate specific antigen (TPSA) level
The primary efficacy variable from 12.82 ng/mL to 13.01 ng/mL in serum TPSA level and 2 weeks of treatment.

Secondary Outcome Measures

Full Information

First Posted
April 8, 2021
Last Updated
April 8, 2021
Sponsor
Jiangnan University
Collaborators
Affiliated Hospital of Jiangnan University
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1. Study Identification

Unique Protocol Identification Number
NCT04839055
Brief Title
The Effects of Coenzyme A Combined With Abiraterone on Patients With CRPC
Acronym
CoA-CRPC
Official Title
The Purpose of This Study is to Compare the Therapy Effects and Clinical Safety of a Regulatory Metabolic Compound, Coenzyme A (CoA) With a Marketed Drug, Abiraterone, in Chinese Patients With Castration-resistant Prostate Cancer (CRPC) .
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 18, 2021 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangnan University
Collaborators
Affiliated Hospital of Jiangnan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the therapy effects and clinical safety of a regulatory metabolic compound, coenzyme A (CoA) with a marketed drug, abiraterone, in Chinese patients with castration-resistant prostate cancer (CRPC) .
Detailed Description
Prostate Cancer (PCa) has developed into the second most common cancer in men. In The United States, PCa has the highest morbidity in man. In China, the incidence rate is lower than in Europe and the US, but it is growing faster and faster. Androgen deprivation therapy (ADT) has been the most commonly used treatment for men with advanced prostate cancer for hundreds of years, effective in more than 85 percent of cases, but usually after 20 months or so, half of patients will inevitably develop castration-resistant prostate cancer (CRPC), which will become resistant to ADT, and patients will relapse. There are several treatments that are trying to address this problem. Such as the chemotherapy docetaxel, cabataxel, and the radioactive drug radium 223 dichloride; PARP inhibitor olaparib, but the efficacy is limited. For finding some new pathways and targets to treat CRPC, a model of PCa persister cell was first been established at a cellular level in this study. In light of the new target, we first find a being used clinically drug, Coenzyme A (CoA), through prescription sieve to treat enzalutamide or abiraterone drug-fast CRPC patients. CoA functions as an acyl group carrier and assists in transferring fatty acids from the cytoplasm to mitochondria. It is also involved in the oxidation and catabolism of fatty acids. There is an efficient drug action at a cellular level and in animals, and we look forward to it at clinical utility.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Castration-resistant Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Coenzyme A 200U
Arm Type
Experimental
Arm Description
Coenzyme A 200U per day
Arm Title
Placebo Comparator: Placebo
Arm Type
Placebo Comparator
Arm Description
Abiraterone without coenzyme A
Intervention Type
Drug
Intervention Name(s)
Coenzyme A Combined With Abiraterone
Intervention Description
Abiraterone 4 pieces per day. Coenzyme A 200U
Intervention Type
Drug
Intervention Name(s)
Abiraterone
Intervention Description
Abiraterone
Primary Outcome Measure Information:
Title
Total prostate specific antigen (TPSA) level
Description
The primary efficacy variable from 12.82 ng/mL to 13.01 ng/mL in serum TPSA level and 2 weeks of treatment.
Time Frame
2 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - 18-100 years of age combined use with abiraterone or enzalutamide CRPC Exclusion Criteria: - pregnancy acute liver disease or hepatic dysfunction, as determined by levels of alanine aminotransferase (ALT) or aspartate aminotransferase levels (AST) more than 2-fold the upper normal limit nephrotic syndrome or serum creatinine (Cr) ≥2-fold the upper normal limit and creatine phosphokinase (CK) more than 3-fold the upper normal limit primary hypothyroidism psychiatric patients poorly controlled hypertension, as indicated by a Systolic Blood Pressure >180 mmHg or Diastolic Blood Pressure >110 mmHg using contraceptive agent using immunosuppressive drugs, prohibited medication or other non-PCa drugs long-term using CoA drug
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YongQuan Chen, MD
Phone
051013812517168
Email
yqchen@jiangnan.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Rong Wang, EM
Phone
051018652457101
Email
840174458@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YongQuan Chen, MD
Organizational Affiliation
Jiangnan University
Official's Role
Study Chair
Facility Information:
Facility Name
Jiangnan University
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YongQuan Chen, MD
Phone
051013812517168
Email
yqchen@jiangnan.edu.cn
First Name & Middle Initial & Last Name & Degree
rong wang, EM
Phone
051018652457101
Email
W0826R@outlook.com
First Name & Middle Initial & Last Name & Degree
YongQuan Chen, MD

12. IPD Sharing Statement

Learn more about this trial

The Effects of Coenzyme A Combined With Abiraterone on Patients With CRPC

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